Clinical eTMF Specialist

Scorpion Therapeutics; Kennesaw (GA); On-site; USD 75,000 - 110,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical eTMF Specialist to manage and ensure high-quality electronic Trial Master File across clinical trial lifecycles. You will coordinate TMF activities, perform quality checks and drive inspection readiness with cross-functional teams.

The role requires a Bachelor's in Life Sciences or related field, 2–4 years in TMF/eTMF management, and hands-on use of systems like Florence or Veeva Vault. Travel is required.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2–4 years of clinical trial documentation and TMF/eTMF management experience.
• Strong knowledge of ICH-GCP, FDA, EMA.
• Hands-on with eTMF systems (e.g., Florence, Veeva Vault).
• Excellent organizational and communication skills; ability to travel.

Responsibilities

• Maintain compliance with GCP, ICH guidelines, SOPs, and regulations.
• Perform quality checks, monitor metrics, and address gaps.
• Collaborate with Clinical Operations, QA, Regulatory Affairs, CROs, and study sites.
• Support inspection readiness, audits, and system upgrades.
• Develop SOPs and training materials.

Skills

Organizational skills

Communication

Teamwork

Attention to detail

Education

Bachelor's degree in Life Sciences or related field

Tools

Florence

Veeva Vault

Job description

Role:

Clinical eTMF Specialist responsible for managing and ensuring quality control of the electronic Trial Master File throughout clinical trial lifecycles.

Responsibilities:

maintain compliance with GCP, ICH guidelines, SOPs, and regulations; perform quality checks, monitor metrics, and address gaps; collaborate with Clinical Operations, QA, Regulatory Affairs, CROs, and study sites; support inspection readiness, audits, and system upgrades; develop SOPs and training materials.

Requirements:

Bachelor's in Life Sciences, Clinical Research, or related field; 2-4 years in clinical trial documentation, TMF/eTMF management; solid knowledge of ICH-GCP, FDA, EMA; hands-on with eTMF systems (e.g., Florence, Veeva Vault); experience with TMF CDISC reference model preferred; strong organizational, communication, and teamwork skills; ability to travel.

HighValue:

clinical trials, eTMF systems, GCP compliance, regulatory readiness, cross-functional collaboration.

WorkSetup:

not specified; willingness to travel required.